APPLICATION
ANDA204165
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-15
LATEST ACTION
2023-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 300MG BASE · TABLET · ORAL
Approval history
2023-01-23Labeling · Supplement 25 · standardAP
2022-03-31Labeling · Supplement 18 · standardAP
2019-12-13Labeling · Supplement 7 · standardAP
2019-12-13Labeling · Supplement 8 · standardAP
2019-12-13Labeling · Supplement 14 · standardAP
2019-12-13Labeling · Supplement 12 · standardAP
2019-12-13Labeling · Supplement 9 · standardAP
2019-12-13Labeling · Supplement 15 · standardAP
2016-05-10Labeling · Supplement 4 · standardAP
2014-09-15UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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